Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases (NCT05996354) | Clinical Trial Compass
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Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
China10 participantsStarted 2022-03-01
Plain-language summary
There are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients who are ≥ 18 years old and ≤ 85 years old；
✓. Patients with aortic arch diseases (involving aortic arch aneurysm, aortic dissection, aortic pseudoaneurysm, aortic ulcer, and intermural hematoma);
✓. Anatomical criteria, including:
✓. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
✓. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 15 mm;
✓. The diameter of the anchored area of the innominate artery is between 10-16 mm, the diameter of the anchored area of the left common carotid artery is between 5-12 mm, and the diameter of the anchored area of the left subclavian artery is between 5-12 mm. Anchorage zone length is greater than or equal to 15 mm;
✓. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
✓. Have a suitable iliac, femoral, and superior arch arterial approach;
Exclusion criteria
✕. Patients with general or local infections that may increase the risk of endovascular graft infection;
✕. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to make the stent-graft difficult to adhere to or affect the patency of the stent;
What they're measuring
1
Immediate technical success rate
Timeframe: Immediate intraoperative
Trial details
NCT IDNCT05996354
SponsorChina National Center for Cardiovascular Diseases
✕. Patients with neck vascular surgery within 3 months;
✕. Patients with severe carotid or subclavian artery stenosis, calcification;
✕. Patients with a history of acute coronary syndrome within 6 months:
✕. Patients with transient ischemic attack (TIA) or ischemic stroke within 3 months;
✕. Patients with preoperative hepatic and renal dysfunction, \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper limit of normal level by a factor of five; Serum creatinine (Cr) \>150umol/L\];
✕. Patients with history of bleeding or coagulopathy, who cannot receive antiplatelet therapy;